Safety, Tolerability and Symptomatic Efficacy of the ROCK-Inhibitor Fasudil in Patients with Parkinson's Disease (ROCK-PD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

3 Feb 2026 → ongoing

Decision date (initial)

2024-09-30

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-517413-33-00

EudraCT number

2021-003879-34

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Efficacy

To establish the combined safety and tolerability profile of oral Fasudil solution over 22 days

Conditions and MedDRA coding

Idiopathic Parkinson's Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Patients with a diagnosis of at least probable PD according to MDS criteria (Postuma et al. MovDis 2015) and
2. Hoehn & Yahr stage 1 – 3
3. must be non-fluctuating (no wearing-off, no dyskinesia) and stable on symptomatic PD medication for at least 6 weeks
4. age: 30 - 80 years
5. Women of childbearing potential must be non-lactating and surgically sterile or using a highly effective method of birth control and have a negative pregnancy test. Acceptable methods of birth control with a low failure rate (i.e. less than 1% per year) when used consistently and correct are for example implants, injectables, combined oral contraceptives, hormonal intrauterine devices (IUDs), sexual abstinence or vasectomized partner
6. Capable of thoroughly understanding all information given and giving full informed consent according to GCP

Exclusion criteria 13

1. Atypical, secondary Parkinsonian syndromes, PD mimics, or any other medical condition known to have an association with Parkinsonian syndromes, which might confound or obscure the diagnosis of PD
2. Patients with a history of intracranial bleeding, known intracerebral aneurysms or Moyamoya disease, or positive family history for the above. If only family history positive, MR- or x-ray-based cranial imaging not older than 24 months must confirm absence of bleeding, aneurysms, or Moyamoya
3. Presence of any concomitant life-threatening disease or impairment likely to interfere with functional assessment
4. Patients with known arterial hypotension (resting blood pressure <90/60 mmHg) or previous hypotensive episodes or requiring treatment for increasing of blood pressure, such as fludrocortisone, midodrine, etilefrine, cafedrine, or theodrenaline
5. Patients with an uncontrollable or unstable arterial hypertensive disease (resting blood pressure >180 mmHg systolic and/or >120 mmHg diastolic under current antihypertensive medication)
6. Known pulmonary hypertension and any medication prescribed for treatment of pulmonary hypertension
7. Confirmed hepatic insufficiency or abnormal liver function (stable ASAT and/or ALAT greater than 3 times the upper limit of the normal range) and determined to be nontransient through repeat testing
8. Renal insufficiency with a glomerular filtration rate (GFR) <60 ml/min/1,73m² (calculated by MDRD equation) and determined to be non-transient through repeat testing
9. Major psychiatric disorder, significant cognitive impairment or clinically evident dementia precluding evaluation of symptoms
10. Hypersensitivity to any component of the IMP
11. Liable to be not cooperative or comply with the trial requirements (as assessed by the investigator), or unable to be reached in the case of emergency
12. Pregnant or breast-feeding females or females with childbearing potential, if no adequate contraceptive measures are used
13. Previous participation in another clinical study involving trial medication within the preceding 12 weeks or five terminal half times of the longest to be eliminated trial medications (whichever is longer) or previous participation in this trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Combined occurrence of intolerance (termination of treatment because of treatment-related AE) and occurence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs [time frame: from day 1 to day 22]

Secondary endpoints 9

1. Occurrence of intolerance (termination of treatment because of treatment-related AE) [time frame: from day 1 to day 22].
2. Occurrence of self-reported and pre-defined (laboratory, vital signs) treatment-related SAEs [time frame: from day 1 to day 22, and day 1 to day 50].
3. the change of MDS-Unified PD Rating Scale (MDS-UPDRS) each part I to IV [time frame: part I and II from day 1 to day 22, and day 1 to day 50; time frame: part III and IV from day 1 to day 10, day 1 to day 22, and day 1 to day 50]
4. the change of MDS-Unified PD Rating Scale (MDS-UPDRS) score part I to IV
5. the change of 8-item PD Quality of Life Scale (PDQ-8) [time frame: from day 1 to day 22, and day 1 to day 50]
6. the change of PD Non-Motor Symptom Questionnaire (NMSQuest) [time frame: from day 1 to day 10, day 1 to day 22, and day 1 to day 50]
7. the change of Montreal Cognitive Assessment (MoCA) [time frame: from day 1 to day 22, and day 1 to day 50]
8. the change of Becks depression inventory-II (BDI-II) [time frame: from day 1 to day 22, and day 1 to day 50],
9. the Global Impression of Improvement score (CGI-I [clinician], PGI-I [patient]) [time point: at day 10, 22 and day 50].

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

Sponsor organisation

Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

Address

Ismaninger Strasse 22, Au-Haidhausen Au-Haidhausen

City

Munich

Postcode

81675

Country

Germany

Scientific contact point

Organisation

Klinikum rechts der Isar der TU Muenchen AöR

Contact name

Prof Dr. Paul Lingor

Public contact point

Organisation

Klinikum rechts der Isar der TU Muenchen AöR

Contact name

Prof Dr. Paul Lingor

Locations

1 EU/EEA country · 13 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 15 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications